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| ID | Type | Description | Link |
|---|---|---|---|
| IND 106541 | Other Identifier | FDA | |
| K23AG040708 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| The American Geriatrics Society | OTHER |
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This study will test the role of high dose vitamin D supplementation in prevention of acute respiratory infection in older nursing home residents. The investigators hypothesize that residents on high dose vitamin D supplementation will have a lower incidence of acute respiratory infection that those on standard dose vitamin D supplementation.
This study is a double-blinded, parallel group, randomized controlled phase II trial of oral high vs. standard dose vitamin D3 supplementation administered monthly for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Vitamin D | Experimental | 100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day. |
|
| Standard Dose Vitamin D | Active Comparator | 12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose Vitamin D | Drug | Vitamin D3 100,000 IU monthly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Acute Respiratory Infections (ARIs) | ARIs defined as upper or lower respiratory infections | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Acute Respiratory Infections | ARIs resulting in emergency department visits or hospitalizations | 12 month |
| Time to First ARI | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adit A Ginde, MD, MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27861708 | Result | Ginde AA, Blatchford P, Breese K, Zarrabi L, Linnebur SA, Wallace JI, Schwartz RS. High-Dose Monthly Vitamin D for Prevention of Acute Respiratory Infection in Older Long-Term Care Residents: A Randomized Clinical Trial. J Am Geriatr Soc. 2017 Mar;65(3):496-503. doi: 10.1111/jgs.14679. Epub 2016 Nov 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose Vitamin D | 100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day. High Dose Vitamin D: Vitamin D3 100,000 IU monthly Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms. |
| FG001 | Standard Dose Vitamin D | 12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day. Standard Dose Vitamin D: Vitamin D 12,000 IU monthly Placebo: Placebo monthly Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Vitamin D | 100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day. High Dose Vitamin D: Vitamin D3 100,000 IU monthly Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Acute Respiratory Infections (ARIs) | ARIs defined as upper or lower respiratory infections | Posted | Number | events | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose Vitamin D | 100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day. High Dose Vitamin D: Vitamin D3 100,000 IU monthly Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adit Ginde, MD, MPH, Professor of Emergency Medicine | University of Colorado School of Medicine | 720-848-6777 | adit.ginde@ucdenver.edu |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Standard Dose Vitamin D |
| Drug |
Vitamin D 12,000 IU monthly |
|
| Placebo | Drug | Placebo monthly |
|
| Usual Care | Dietary Supplement | Usual care of 0-1000 IU vitamin D daily. This is present in both study arms. |
|
| Change in 25-hydroxyvitamin D (25OHD) Level | Baseline and 12 months |
| Change in Parathyroid Hormone Level | Baseline and 12 months |
| Falls | 12 months |
| Fractures | 12 months |
| Number of Upper Respiratory Infections | 12 months |
| Number of Lower Respiratory Infections | 12 months |
| Number of Influenza-like Illnesses | 12 months |
| Incident Kidney Stones | 12 months |
| Incident Hypercalcemia | 12 months |
| Death | 12 months |
| Number of Urinary Tract Infections | 12 months |
| Number of Other Infections | 12 months |
| Standard Dose Vitamin D |
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day. Standard Dose Vitamin D: Vitamin D 12,000 IU monthly Placebo: Placebo monthly Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 25-hydroxyvitamin D level | Mean | Standard Deviation | ng/ml |
|
|
|
| Secondary | Severity of Acute Respiratory Infections | ARIs resulting in emergency department visits or hospitalizations | Posted | Number | events | 12 month |
|
|
|
| Secondary | Time to First ARI | Posted | Number | Hazard Ratio | 12 months |
|
|
|
| Secondary | Change in 25-hydroxyvitamin D (25OHD) Level | Posted | Mean | Standard Error | ng/mL | Baseline and 12 months |
|
|
|
| Secondary | Change in Parathyroid Hormone Level | Issue relating to sample collection/processing precluded measurement of PTH level in the trial | Posted | Baseline and 12 months |
|
|
| Secondary | Falls | Posted | Number | Events | 12 months |
|
|
|
| Secondary | Fractures | Posted | Number | events | 12 months |
|
|
|
| Secondary | Number of Upper Respiratory Infections | Posted | Number | events | 12 months |
|
|
|
| Secondary | Number of Lower Respiratory Infections | Posted | Number | events | 12 months |
|
|
|
| Secondary | Number of Influenza-like Illnesses | collected together with lower respiratory infections (not as a separate category) | Posted | 12 months |
|
|
| Secondary | Incident Kidney Stones | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Incident Hypercalcemia | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Death | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Urinary Tract Infections | Posted | Number | events | 12 months |
|
|
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| Secondary | Number of Other Infections | Posted | Number | events | 12 months |
|
|
|
| 9 |
| 55 |
| 53 |
| 55 |
| EG001 | Standard Dose Vitamin D | 12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day. Standard Dose Vitamin D: Vitamin D 12,000 IU monthly Placebo: Placebo monthly Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms. | 13 | 52 | 49 | 52 |
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| Cardiac disorders | Cardiac disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Ear and labyrinth disorders | Ear and labyrinth disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Endocrine disorders | Endocrine disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Eye disorders | Eye disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
|
| Gastrointestinal disorders | Gastrointestinal disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| General disorders | General disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Hepatobiliary disorders | Hepatobiliary disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Immune system disorders | Immune system disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
|
| Infections and infestations | Infections and infestations | Adverse events were recorded at the organ system level using the MedDRA classification system |
|
| Injury, poisoning, and procedural complications | Injury, poisoning and procedural complications | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Investigations | Investigations | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Metabolic and nutrition disorders | Metabolism and nutrition disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Neoplasms | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Adverse events were recorded at the organ system level using the MedDRA classification system |
|
| Nervous system disorders | Nervous system disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Psychiatric disorders | Psychiatric disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Renal and urinary disorders | Renal and urinary disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Reproductive system disorders | Reproductive system and breast disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Skin and subcutaneous disorders | Skin and subcutaneous tissue disorders | Adverse events were recorded at the organ system level using the MedDRA classification system |
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| Social circumstances | Social circumstances | Adverse events were recorded at the organ system level using the MedDRA classification system |
|
| Surgical and medical procedures | Surgical and medical procedures | Adverse events were recorded at the organ system level using the MedDRA classification system |
|
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| D044342 |
| Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |